Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effectiveness of oral dydrogesterone in preventing miscarriage in threatened abortion. Half of participants will receive oral dydrogesterone, while the other half will receive oral placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dydrogesterone | Active Comparator | dydrogesterone 10 mg by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. |
|
| Placebo | Placebo Comparator | placebo by mouth every 12 hours until 1 week after bleeding stops or until 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone | Drug | Dydrogesterone tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| continue pregnancy more than 20 weeks gestation | percentage of cases with continue pregnancy more than 20 weeks gestation | at 20 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| preterm delivery less than 34 weeks | percentage of delivery less than 34 weeks | at 34 weeks gestation |
| preterm delivery less than 37 weeks | percentage of delivery less than 37 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, M.D. | Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30157093 | Background | American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin No. 200: Early Pregnancy Loss. Obstet Gynecol. 2018 Nov;132(5):e197-e207. doi: 10.1097/AOG.0000000000002899. | |
| 26800266 | Background | Mirza FG, Patki A, Pexman-Fieth C. Dydrogesterone use in early pregnancy. Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000033 | Abortion, Threatened |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo tablet |
|
| at 37 weeks gestation |
| placenta previa | percentage of placenta previa | 31 weeks |
| abruptio placenta | percentage of abruptio placenta | 31 weeks |
| Intrauterine growth restriction | percentage of intrauterine growth restriction | 31 weeks |
| neonatal complications | percentage of newborn with respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, death | 31 weeks |
| side effects | percentage of side effects such as headache, nausea/vomiting | 6 weeks |
| compliance | percentage of complete drug use | 6 weeks |
| maternal satisfaction | percentage of good satisfaction | 6 weeks |
| time until bleeding stops | time from first bleeding until bleeding stops | 6 weeks |
| 14670641 | Background | Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2003 Dec 10;46 Suppl 1:S7-S16. doi: 10.1016/j.maturitas.2003.09.014. |
| 16293412 | Result | Omar MH, Mashita MK, Lim PS, Jamil MA. Dydrogesterone in threatened abortion: pregnancy outcome. J Steroid Biochem Mol Biol. 2005 Dec;97(5):421-5. doi: 10.1016/j.jsbmb.2005.08.013. Epub 2005 Nov 15. |
| 20005647 | Result | Pandian RU. Dydrogesterone in threatened miscarriage: a Malaysian experience. Maturitas. 2009 Dec;65 Suppl 1:S47-50. doi: 10.1016/j.maturitas.2009.11.016. Epub 2009 Dec 14. |
| 20007011 | Result | El-Zibdeh MY, Yousef LT. Dydrogesterone support in threatened miscarriage. Maturitas. 2009 Dec;65 Suppl 1:S43-6. doi: 10.1016/j.maturitas.2009.11.013. Epub 2009 Dec 14. |
| D011083 |
| Polycyclic Compounds |